Lifescan Surestep Pro Glucose Control/Linearity Solutions
FDA 510(k) K971014 · Lifescan, Inc.
510(k) numberK971014
Submission
- Device name
- Lifescan Surestep Pro Glucose Control/Linearity Solutions
- Applicant
- Lifescan, Inc.
Milpitas, CA, US - Received
- March 20, 1997
- Decision date
- April 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Lifescan Surestep Pro Glucose Control/Linearity Solutions cleared by the FDA?
Lifescan Surestep Pro Glucose Control/Linearity Solutions (K971014) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 34 days after the submission was received.
What is the product code of K971014?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.